GMP Q7 Management System
GMP Q7 Management System
API manufacture documented the way an inspector reads it: quality unit, batch record, release decision.
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Written by practising auditors with 20+ years in the field.
By document type
| Category | Files |
|---|---|
| Manuals | 3 |
| Procedures & SOPs | 24 |
| Forms & Records | 29 |
| Checklists & Audit Tools | 7 |
| Registers, Logs & Matrices | 3 |
| Job Descriptions & Organisation | 2 |
| Training & Awareness | 4 |
| Guides & Work Instructions | 3 |
Key documents
| Reference | Document | Format |
|---|---|---|
| GMP 01 - AGS Quality Manual | Word | |
| D139 | GMP Q7 Compliance Matrix | Excel |
| CHK-01 | GMP Self-Inspection Checklist | Word |
| SOP-QA-35 | SOP for Batch Record Review and Product Release | Word |
| SOP-QA-07 | SOP for Deviation and Investigation | Word |
| SOP-QA-16 | SOP for Out of Specification (OOS) | Word |
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Overview
ICH Q7, the Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, is the harmonised guideline developed under the International Council for Harmonisation to fix GMP expectations for API manufacture. Its object is that an API holds the quality and purity characteristics it is represented to possess, which is what protects the finished medicinal product built on it. It reaches across chemical synthesis, extraction, cell culture, fermentation and recovery from natural sources, taking in intermediates as well as final APIs, with controls tightening as processing moves closer to the API itself.
The guideline turns on an independent quality unit and the decisions it owns: batch record review and product release, deviation and out-of-specification investigation, change control, and the handling of complaints, returns and recalls. Around that sit personnel qualification and hygiene; buildings, facilities and equipment; documentation and records; materials management; process and in-process controls; packaging and labelling; storage and distribution; laboratory controls and stability testing; and validation of processes, cleaning and analytical methods, with oversight of contract manufacturers, agents, brokers and repackagers. ICH Q7 is adopted into regional regulatory frameworks, recognised by the FDA and EMA, and underpins EU GMP Part II. Being a guideline rather than a certifiable standard, adherence is tested by regulatory inspection and customer audit rather than by a certificate.
What this system covers
- Quality unit governance — batch record review, product release and GMP self-inspection
- Deviation, out-of-specification and laboratory investigation, with non-conforming product and rework
- Validation and qualification — process, cleaning and analytical method validation, equipment qualification
- Data integrity — computerised system validation, ALCOA+ principles and good documentation practice
- Materials and supplier oversight — incoming inspection, approved external providers and vendor quality audit
- Facilities and hygiene — personnel hygiene, cleaning and sanitation, line clearance, calibration and maintenance
- Market complaints, product recall and mock recall exercises
- Stability protocols, label and carton issue control, and GMP training and knowledge assessment
Who it's for
Quality unit heads and QA managers at API and intermediate manufacturers preparing for an FDA or EMA inspection, or for a customer audit testing EU GMP Part II compliance before a supply agreement is signed. They finish with the SOPs, forms and self-inspection tools an inspection expects to find in use, drafted against ICH Q7 and waiting to be made site-specific.
Everything you get
Every toolkit gives you a full set of working documents for your standard, ready to edit and use.
Native Microsoft files. Add your logo and adapt every document to how you work.
Your full toolkit arrives as a ZIP the moment payment clears.
One purchase covers everyone in your organisation. No per-seat fees.
Built by people who run real audits, so the content matches what assessors check.
One payment, perpetual licence for your organisation. No subscriptions, no renewals.
Full refund if your files are faulty, incomplete or not as described and we can't put it right
Frequently asked questions
What exactly do I receive?
A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.
Are the documents really editable?
Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.
Does this certify my organisation?
No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.
How is it delivered?
Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.
Do I get updates?
Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.
What is your refund policy?
These are digital products, so once a toolkit has been downloaded we cannot take it back. If you have not downloaded yet, contact us and we will cancel the order and refund you in full. We also refund in full if the files are damaged, incomplete, or not what the product page described.
Cannot find your standard?
Tell us which scheme you work to. We will point you to the right toolkit.
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